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Abstract
An isocratic technique was developed for the analysis of leuprolide acetate by high performance liquid chromatography (HPLC) using 220 nm UV detection, C18 MICROSORB-MVTM column (4.6 mm × 15 cm), mobile phase (0.03 M, 77% dibasic ammonium phosphate buffer: 23% acetonitrile), and 2.0 mL/min flow rate.
The coefficient of variation (C.V.) for precision and proportionality assays was lower than 2% for all concentrations studied. The detection limit and tailing factor for leuprolide acetate were 100 ng/mL (signal-to-noise ratio of 3:1) and 1.16-1.26, respectively.
ACKNOWLEDGMENT
We gratefully acknowledge TAP pharmaceuticals Inc. (Deerfield, IL) for generously providing leuprolide acetate.